1. Field of the Invention
The invention is in the field of detecting viable bacteria or microorganisms, if any, upon completion of a sterilization cycle, using rapid biological detection systems. Therefore, the invention can be used to determine whether bacteria are destroyed in a sterilization cycle.
2. Description of the Background Art
The detection of remaining viable bacteria or microorganisms after a sterilization cycle is important in the prevention of infection and the spread of diseases. Before using instrumentation in surgical and dental procedures, personnel need to know if the instruments have been properly sterilized, usually immediately after the sterilization cycle has been completed. Unfortunately, conventional tests require a lengthy time and complicated process before the sufficiency of the cycle can be evaluated.
For example, a biological indicator can be included in the sterilization run, but typically the indicator consists of bacteria that must be grown in culture media at an elevated temperature for a period of up to 7 days, usually about one to two days, before the adequacy of the sterilization can be determined. At the end of the culture period, the viability of any bacteria remaining after the sterilization is determined by measuring bacterial growth. If there is no growth, then the sterilization cycle was complete and the bacteria adequately destroyed. If growth occurs, then the sterilization cycle was faulty or incomplete.
Most of the conventional growth tests are conducted at test facilities outside the medical or dental offices, which add to the delay and cost in obtaining the results. Also, the bacteria may be transferred from its sterilization container to the culture media, increasing the chances of contamination and mishandling. Oftentimes the instruments contained within the sterilization cycle cannot be quarantined and must be used before the results of the bacterial growth test are known. In situations where the instruments have been utilized and the sterilization cycle was inadequate, personnel must locate the patient for proper treatment to control the possibility of infection.
Therefore, it is highly desirable to determine the results of a sterilization cycle within a short period of time, such that the sterility of the instruments is known before their use on a patient. It also is desirable for the results to accurately reflect the completeness of the sterilization run, in particular, especially as to the inactivation or destruction of the viable bacteria or microorganisms.